Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease

Completed

• Conditions: Cardiomyopathy; Chronic Kidney Disease; Anemia

• Registration Number: NCT00883415
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

This study examines patients with chronic kidney disease-related anemia and measures changes in the metabolism of the heart using FDG/PET scanning, before and 6 months after their health-care provider has initiated anemia management therapy with the FDA-approved drug darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia. The investigators hypothesize that the heart has abnormal metabolism with the anemia of chronic kidney disease but this improves after correction of this anemia with darbepoetin alfa.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2020-02-27
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Results First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participant must receive care at the VAMHCS (VA Hospital) in Baltimore
• Diagnosed with CKD stage 3 to 5 (eGFR of 60 ml/min/1.73m2) and not expected to initiate renal replacement therapy within 6 months
• Anemia related CKD.
• The last 2 serum hemoglobin (Hb) values less than 11.0 gm/dl but greater than 8.0 gm/dl
• Greater than 18 years of age
• Assessed to be clinically stable by the clinician

Exclusion Criteria

• Need for hemodialysis, peritoneal dialysis, or transplantation at the time of enrollment or projected to start within 6 months after enrollment
• Low functional capacity including inability to walk a flight of stairs with a bag of groceries (NYHA Class III/IV Heart Failure)
• Prior erythropoietic agents within last 12 weeks
• TSAT < 15% and not receiving the recommended dose for iron deficiency
• Uncontrolled hypertension defined as greater than 180 mm Hg systolic or 110 mm Hg diastolic
• Potentially "brittle" diabetes with the propensity for symptomatic hypoglycemia after a 6 hour fast
• New diagnosis or ongoing therapy for Cancer
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change to Myocardial Glucose Uptake as Measured by Fluoro-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Scan From Pre-treatment Compared to 6 Months After Anemia Therapy Initiation.	6 months	Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g

Trial Locations

Locations (1)

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States